|Theme||Transitional provisions – significant changes|
|Target Audience||Manufacturers, Notified Bodies|
|Product concerned||Medical Devices that are covered by a valid certificate issued in accordance with a Directive and that continues to be placed on the market after the date of application of the applicable Regulation (Legacy Devices)|
|Regulatory references||MDR (EU) 2017/745
|Documents mentioned||NBOG’s Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System|
EN – Article 120 of MD Regulation provides that certificates issued in accordance with Directives AIMD and MD remain valid until the end of their validity and until 26 May 2024 at the latest, provided that the manufacturer does not make any significant change in the design or intended purpose of the device. This guidance clarifies what is to be considered a significant change and how the assessment should be carried out by the Notified Body (NB).
Any plan for change to an MD should first be assessed against the requirements of the AIMD/MD Directives as part of the certification contract between the manufacturer and its NB to determine whether it is a substantial change within the meaning of the Directives, using the NB’s published guides and NBOG’s Best Practice Guide 2014-3.
The NB will then assess whether it is a significant change in the design or intended purpose of the device in relation to Article 120(3) of the Regulation. This guide provides 5 flowcharts to identify which changes are to be considered significant.
Thus, some changes may be considered substantial within the meaning of the AIMD/MD Directives, but not significant within the meaning of Article 120 of the Regulation, because they do not impact the design or purpose of the device.
As changes to AIMD/MD certificates are not possible after May 26, 2021, the NB will need to provide written confirmation that the change being assessed is not a significant change in terms of Article 120(3) of the Regulation and that the AIMD/MD certificate remains valid.